Thermo Fisher Scientific KingFisher™ Apex Dx Purification Operating instructions

Brand: Thermo Fisher Scientific

Model: KingFisher™ Apex Dx Purification

Type: Operating instructions

For In Vitro Diagnostic Use.

KingFisher™ Apex Dx Puriﬁcation Instrument

INSTRUCTIONS FOR USE | IVD

Catalog NumberB5400900P

Document Part Number 100123011

Publication Number MAN0026509

Revision B.0

Life Technologies Holdings Pte Ltd |

Block 33 | Marsiling Industrial Estate

Road 3 | #07-06, Singapore 739256

UKRP

Life Technologies Limited | 3 Fountain

Drive, Inchinnan Business Park | Paisley

PA49RF, Scotland, United Kingdom

Life Technologies Europe B.V.

Kwartsweg 2, 2665 NN Bleiswijk The

Netherlands

Revision history:Pub.No. MAN0026509

Revision Date Description

B.0 5 July 2023

•The document part number was added to the cover page.

•Information directing the user to contact Technical Support for Thermo Fisher-developed IVD

reagents and protocols was added to the Import/Export section.

•Information directing the user to contact Technical Support to secure a protocol compatible with

IVD mode was added to the Import/Export section.

A.0 27 April 2023 New document for KingFisher™ Apex Dx Puriﬁcation Instrument.

The information in this guide is subject to change without notice.

DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE

LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR

ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.

Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these

products, you accept the terms and conditions of all applicable Limited Use Label Licenses.

NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under any

process, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled by

Thermo Fisher Scientiﬁc, either expressly, or by estoppel.

TRADEMARKS: All trademarks are the property of Thermo Fisher Scientiﬁc and its subsidiaries unless otherwise speciﬁed.

Contents

■CHAPTER1Productinformation .................................................. 6

Productdescription ............................................................. 6

Intendeduse ................................................................... 6

Orderingconﬁgurations .......................................................... 6

Product overview ............................................................... 7

Instrument overview ......................................................... 7

User interface overview ...................................................... 9

General login functionalitydescription ............................................ 11

Upon receiving thedevice ....................................................... 11

Precautions foruse ........................................................ 12

Magnetic heads ........................................................... 12

Guidelines for unpacking theinstrument ...................................... 13

First time instrumentsetup .................................................. 13

Instrument components and plasticcompatibility .................................. 16

Heating block and compatible plate .......................................... 16

Magnetichead ............................................................ 18

Tip comb and platecompatibility ............................................ 20

■CHAPTER2Methods ............................................................. 21

Change password .............................................................. 21

Create, edit, or deleteusers ..................................................... 21

Access IVD protocol and load to instrument memory ............................... 22

Run puriﬁcationkit ............................................................. 22

Abortrun ..................................................................... 24

Turn o theinstrument .......................................................... 24

Change heat block/magnetichead ............................................... 24

Unload heatingblock ....................................................... 24

Unload magnetichead ..................................................... 25

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 3

■CHAPTER3Softwareapplications .............................................. 27

About the user interface ........................................................ 27

Users and roles ............................................................ 27

Diomni™ and SAE integration ................................................ 27

IVD mode(local) ............................................................... 29

Switch instrumentmode .................................................... 29

Overview of user interface controls ............................................... 30

Home screen .............................................................. 30

Menu screen .............................................................. 31

Settings screen ............................................................ 31

Protocolsettings .......................................................... 33

Soundsettings ............................................................ 34

About .................................................................... 34

Usersettings .............................................................. 35

Instrument screen ......................................................... 36

Protocol overview .............................................................. 37

Import/Export overview ......................................................... 37

Import protocol from a USB memorydevice ................................... 37

Export protocol to a USB memorydevice ..................................... 37

Run history overview ........................................................... 38

Export run report .......................................................... 38

Delete run report .......................................................... 38

Searchruns ............................................................... 38

Telemetrydata ................................................................. 39

■APPENDIXATroubleshooting .................................................... 41

Troubleshootingguide .......................................................... 41

■APPENDIXBMaintenance ....................................................... 44

Regular and preventive maintenance ............................................. 44

Store transportlock ............................................................ 44

Magnetic head maintenance ..................................................... 45

Decontamination procedure ..................................................... 45

Decontaminateinstrument .................................................. 45

UV decontamination procedure .................................................. 46

UV treat processchamber .................................................. 46

Prepare instrument for transport ................................................. 46

Reﬁt the transportlock ..................................................... 46

Contents

4KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

■APPENDIXCSpeciﬁcations ...................................................... 48

Physicaldimensions ............................................................ 48

Instrumentspeciﬁcations ....................................................... 48

Performancespeciﬁcations ...................................................... 49

■APPENDIXDOrderinginformation .............................................. 51

Orderingconﬁgurations ......................................................... 51

■APPENDIXESafety ............................................................... 53

Safetycompliance ............................................................. 53

■APPENDIXFSymbols on thisinstrument ....................................... 54

Medical devicesymbols ........................................................ 54

Standard safetysymbols ........................................................ 55

■APPENDIXGElectromagnetic compatibility (EMC) standards ................ 56

EMCcompliance ............................................................... 56

Physical injury ................................................................. 57

Electricalsafety ................................................................ 57

Chemicalsafety ................................................................ 59

Biological hazardsafety ......................................................... 60

■APPENDIXHSeriousincidents .................................................. 61

■APPENDIXIDocumentation and support ....................................... 62

Customer and technical support ................................................. 62

Limited product warranty ........................................................ 62

Contents

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 5

Product information

Product description

The Thermo Scientiﬁc™ KingFisher™ Apex Dx Puriﬁcation Instrument is intended for automated transfer

and processing of magnetic particles in a microplate format. The instrument utilizes magnetic heads

covered with a disposable, specially designed tip comb, and plates. The instrument functions without

any dispensing or aspiration parts or devices. Before the run, samples and reagents (including magnetic

particles) are dispensed into the place according to default, uneditable or uncustomizable in vitro

diagnostic (IVD) protocols.

For the product information sheet on the magnetic heads or the quick reference card on instrument

installation see the following documents:

•KingFisher™ Apex Dx Heads Product Information Sheet (Pub. No. MAN0029197)

•KingFisher™ Apex Dx Puriﬁcation Instrument Quick Reference (Pub. Part No. 100109527)

Intended use

The KingFisher™ Apex Dx Puriﬁcation Instrument is intended to automate the process of isolation and

puriﬁcation of nucleic acids, proteins and cells for in vitro diagnostics (IVD) procedures in combination

with a dedicated puriﬁcation kit. The instrument is intended for use by professional users, such as

technicians and physicians trained in molecular biological techniques.

Ordering conﬁgurations

The KingFisher™ Apex Dx Puriﬁcation Instrument is available to order in combination with one of four

dierent magnetics heads as outlined in the following table. The following catalogue numbers are used

for customer ordering purposes only.

Details Cat. no. Cat. no.

B5400910

Cat. no.

B5400920

Cat. no.

B5400930

Cat. no.

B5400940

Instrument

KingFisher™ Apex Dx Puriﬁcation Instrument B5400900P 1 1 1 1

Components of instrument

UV lamp N21447 2 2 2 2

3-mm ﬂat-tip driver MLS 1 1 1 1

6KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

(continued)

Details Cat. no. Cat. no.

B5400910

Cat. no.

B5400920

Cat. no.

B5400930

Cat. no.

B5400940

Heating blocks

PCR Heating Block 24075910 1 — — —

96 Heating Block 24075920 1 1 1 —

96 Deep Well Heating Block 24075930 — 1 1 —

24 Deep Well Heating Block 24075940 — — — 1

Magnetic heads

KingFisher™ Apex Dx 96 PCR Head B24079910 1 — — —

KingFisher™ Apex Dx 96 Combi Head B24079920 — 1 — —

KingFisher™ Apex Dx 96 Deep Well Head B24079930 — — 1 —

KingFisher™ Apex Dx 24 Combi Head B24079940 — — — 1

Product overview

Instrument overview

The KingFisher™ Apex Dx Puriﬁcation Instrument consists of a touch screen control and a process

chamber with lid to protect specimens and processing plates against environmental contamination.

Figure1KingFisher™ Apex Dx Puriﬁcation Instrument front view

1Front lid

2Touch screen

3On/o button

4USB port × 3 (Host)

Chapter1Product information

Product overview 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 7

346

Figure2KingFisher™ Apex Dx Puriﬁcation Instrument rear view

1Power switch

2Power inlet

3Ethernet/LAN port

4USB port (Host) × 2

5RS-232 serial port

6USB port (Device)

Internal layout

The process chamber of the KingFisher™ Apex Dx Puriﬁcation Instrument consists of a turntable with

eight plate stations. The loading position has an illuminated display, while the processing position is

situated over the heating block and underneath the processing head. There are two heating block

stations under the turntable (not shown on picture) that can be selected for applying to the processing

position.

The processing head consists of two vertically moving platforms—the magnetic head holder, and the

tip comb holder. The magnetic head holder is used to attach up to two magnetic heads composed of

24 or 96 magnetic rods, while the tip comb holder is used to hold plastic tip combs with 24 or 96 tips.

Chapter1Product information

Product overview

8KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

Figure3Process chamber layout

1Turntable with plate stations (1–8)

2Processing position

3Loading position

4Tip comb holder

5Magnetic head holder

6Shield plate

7Barcode reader

8UV light clip × 2

9UV light socket × 2

User interface overview

Symbol Function

Notiﬁcations screen (For more details, see “Home screen” on page30)

Swipe down from the top of the touch screen

Displays the following information:

•Notiﬁcations

•Internet status

•Storage devices

Chapter1Product information

Product overview 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 9

(continued)

Symbol Function

Menu screen (For more details, see “Menu screen” on page31)

Select Menu

Gives access to the following items:

•Home

•Run history

•Import/Export

•Settings

•Instrument

•User management

Settings screen (For more details, see “Settings screen” on page31)

Select Menu4Settings

Gives access to the following items:

•Localization

•Protocols

•Sound

•Loading position display

•Network share

•About

•Reset factory settings

•Troubleshoot

•View EULA

Instrument screen (For more details, see “Instrument screen” on page36)

Select Menu4Settings

Gives access to the following items:

•Tools

•Magnets

•Heating blocks

Chapter1Product information

Product overview

10 KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

General login functionality description

The KingFisher™ Apex Dx Puriﬁcation Instrument has a login functionality. The user can log in to

the instrument locally or via Security, Auditing, and E-Signature (SAE) server (if Applied Biosystems™

Diomni™ Software and SAE integration is enabled). See “Enable Diomni™ Software and SAE integration”

on page27.

The instrument has two modes: research use only (RUO) and IVD. The purpose of this instructions for

use is solely for IVD mode. The IVD mode is available when logged in locally or via SAE.

When the instrument is used by logging in locally, only locally available IVD protocols can be used and

are not customizable.

When the instrument is used while logged in via SAE, the usage is limited to work with Run tasks

created through Diomni™ Software. The IVD Run tasks are available in IVD mode. The user can switch

between Local-Login and SAE-Login (if enabled).

Upon receiving the device

• Visually inspect the transport package, the instrument and the accessories for any damage

incurred during transit.

• If the carton has been damaged in transit, it is particularly important that you retain it for inspection

by the carrier in case there has also been damage to the instrument.

• Any damage claims must be ﬁled with the carrier. Neither the manufacturer nor its agents can be

held responsible for any damage incurred in transit. Upon receipt of the carrier's inspection report,

arrangements will be made for repair or replacement.

Chapter1Product information

General login functionality description 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 11

Precautions for use

CAUTION! PHYSICAL INJURY HAZARD. Do not remove the instrument cover. There are no

components inside the instrument that you can safely service yourself. If you suspect a problem,

contact technical support.

CAUTION! PHYSICAL INJURY HAZARD. The instrument weighs 56 kg (123 lbs) and requires at

least two people to lift. Use the properprecautions when lifting the instrument to avoid injury..

CAUTION! PHYSICAL INJURY HAZARD. During instrument operation, the heating block

temperature can reach 100°C. Allow it to cool to room temperature before handling.

CAUTION! Before using a cleaning or decontamination method other than those recommended by

Thermo Fisher Scientiﬁc, conﬁrm with Thermo Fisher Scientiﬁc that the proposed method will not

damage the instrument. See “Decontaminate instrument” on page45.

Magnetic heads

WARNING! This product contains very strong permanent magnets. People wearing a pacemaker

or metallic prosthesis should not use this product. A pacemaker or prosthesis may be aected or

damaged if it comes in close contact with a strong magnetic ﬁeld.

There are four kinds of interchangeable magnetic heads with corresponding disposable plastic tip

combs available for the instrument. The magnetic head holder has two positions that can be used to

hold dierent types of magnetic heads.

IMPORTANT! Keep magnetic heads away from each other and other magnets at all times. Clashing of

the magnets can cause serious damage to the magnets.

•Do not place the magnetic head on top of the instrument or on any metal surfaces.

•Do not use metal tools when handling magnetic heads.

•Do not place the magnetic head in close proximity to magnetic tapes, computer discs or other

magnetic storage systems, such as credit cards, as damage can occur due to the strong magnetic

ﬁeld of the magnetic heads.

•Do not place the magnetic heads near a PC display, as this may cause damage to the display.

•When not in use, keep the magnetic heads in their respective storage boxes.

•For details on changing a magnetic head, see “Change heat block/magnetic head” on page24.

Chapter1Product information

Upon receiving the device

12 KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

Guidelines for unpacking the instrument

• To prevent condensation, the instrument should be left in its protective, antistatic plastic wrapping

until the ambient temperature has been reached.

• Retain the original packaging and packing material for future transportation. The packaging is

designed to assure safe transport and minimize transit damage. Use of alternative packaging

materials may invalidate the warranty. Also retain all instrument-related documentation provided by

the manufacturer for future use.

First time instrument setup

The initial installation and initial operational check (IQ/OQ) must be performed by FSEs. Content should

be retained for the instances where there is an emergency by the end user.

1. Connect the power supply cable to the power inlet.

The instrument operates at voltages of 100–240 VAC and the frequency range of 50/60 Hz. Ensure

that the local supply voltage in the laboratory conforms to that speciﬁed on the type label on the

back of the instrument

2. Remove the transport lock screw from the magnet holder.

3. Remove the transport lock screws from the transport lock plate over the tip comb holder.

4. Remove the upper transport lock plate, then lift the tip comb holder and remove the lower

transport lock plate.

Do not discard the parts of the transport lock. The lock is required in case of future transportation

of the instrument (see “Store transport lock” on page44).

Chapter1Product information

Upon receiving the device 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 13

Install the UV light bulbs

1. Insert the UV light bulb into the light clip.

2. Slide the light bulb back and into the light socket.

Power on the instrument

1. Turn on the power switch at the rear of the instrument.

2. Press the on/o button to turn on the instrument.

1. At initial login, create username and password for administrator.

Note: Create a username and password that contains at least six characters, and may contain

upper- and lower-case letters, numbers, and special characters. Not all characters are supported.

IMPORTANT! Only the administrator can create and modify the other user roles.

2. Read the license agreement, then select accept.

3. Choose region.

4. Set date, time, and other selectable options

IMPORTANT! The time set here will be applied in the logging and reporting functions.

Chapter1Product information

Upon receiving the device

14 KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

5. On the Mode selection screen, select IVD mode.

Note: After IVD mode is selected, a new window should open.

Install heating block

1. Select Menu4Instrument.

2. In the Heating blocks section, select Insert for the position (1 or 2). The system will present the

heating block station to allow the user to install the heating block.

3. Scan the heating block to be installed by facing the heating block barcode sticker approximately

8–10 cm from the barcode readinger inside the process chamber.

Note: Alternatively, select the heating block to be installed manually from the list shown on the

screen menu.

4. Place the heating block on the heating block station. Fit the pins on the block into the slots of the

station. Press the block down until it clicks properly into position.

Note: Select Information for details on heating block installation.

5. Select .

Install magnetic head

1. Select Menu4Instrument.

2. Select Insert for the position (1 or 2) to install the magnet.

3. Scan the magnetic head to be installed with the barcode reader or perform manual selection with

the menu.

4. Place the magnetic head onto the holder. Fit the pins on the head into the slots in the holder.

Chapter1Product information

Upon receiving the device 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 15

5. Turn the handle to lock the magnet in place.

Note: Select Information for details on magnetic head installation.

6. Select .

Instrument components and plastic compatibility

Heating block and compatible plate

The instrument uses specially designed barcoded plates for optimal processing. Use of other types of

plates may damage the instrument and compromise the warranty, as well as result in below optimal

performance.

The heating blocks are speciﬁcally designed for the plates listed in the following table to ensure even

heating during sample processing.

For details on changing a heating block, see “Change heat block/magnetic head” on page24.

Heating block Plate

KingFisher™ Apex 24 Deep Well Heating Block,

barcoded (Cat. No. 24075940)

KingFisher™ 24 Deep Well Plate, barcoded (30 µL to

5mL [1], Cat. No. 95040470B)

Chapter1Product information

Instrument components and plastic compatibility

16 KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

(continued)

Heating block Plate

KingFisher™ Apex 96 Deep Well Heating Block,

barcoded (Cat. No. 24075930)

KingFisher™ 96 Deep-Well Plate, barcoded (15–

1000µL [1], Cat. No. 95040450B)

KingFisher™ Apex 96 KF Heating Block, barcoded

(Cat. No. 24075920)

KingFisher™ 96-Well Microplate, barcoded (15–

200µL [1], Cat. No. 97002540B)

KingFisher™ Apex PCR Heating Block, barcoded

(Cat. No. 24075910)

PCR plate (10–80µL [1]), skirted (Cat. No. AB2396 [2])

Chapter1Product information

Instrument components and plastic compatibility 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 17

(continued)

Heating block Plate

Adapter

KingFisher™ Apex 96 PCR Semiskirted Plate Adapter (Cat. No. N21446) or semi-skirted (Cat. No.

AB2496 ) [1]

[1] The fill volume depends on the type of tip comb being used.

[2] Recommended PCR plate

Magnetic head

Magnetic head Tip comb

KingFisher™ Apex Dx 96 PCR Head, barcoded (Cat.

No. B24079910)

KingFisher™ 96 PCR Tip Comb, barcoded (Cat. No.

97002560)

KingFisher™ Apex Dx 96 Deep Well Head, barcoded

(Cat. No. B24079930)

KingFisher™ 96 Tip Comb for Deep Well Magnets,

barcoded (Cat. No. 97002534B)

Chapter1Product information

Instrument components and plastic compatibility

18 KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

(continued)

Magnetic head Tip comb

KingFisher™ Apex Dx 96 Combi Head, barcoded

(Cat. No. B24079920)

KingFisher™ 96 Combi Tip Comb, barcoded (Cat.

No. 97002570)

KingFisher™ Apex Dx 24 Combi Head, barcoded

(Cat. No. B24079940)

KingFisher™ 24 Deep Well Tip Comb, barcoded (Cat.

No. 95040470B)

(also KingFisher™ 24 Combi Tip Comb, barcoded )

Chapter1Product information

Instrument components and plastic compatibility 1

KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use 19

Tip comb and plate compatibility

Tip comb Compatible plates

KingFisher™ 96 Tip Comb for Deep Well Magnets

(Cat. No. 97002534B)

KingFisher™ 96 Deep Well plate (Cat. No.

95040450B)

KingFisher™ 96-Well Microplate (Cat. No.

97002540B)

KingFisher™ 96 Combi Tip Comb (Cat. No.

97002570)

KingFisher™ 96 Deep Well plate (Cat. No.

95040450B)

KingFisher™ 96-Well Microplate (Cat. No.

97002540B)

KingFisher™ 24 Deep Well Tip Comb (Cat. No.

97002610B)

KingFisher™ 24 Deep Well plate (Cat. No.

95040470B)

KingFisher™ 24 Combi Tip Comb (Cat. No.

97002580)

KingFisher™ 24 Deep Well plate (Cat. No.

95040470B)

KingFisher™ 96 PCR Tip Comb (Cat. No. 97002560) PCR plate, skirted (Cat. No. AB2396)

PCR plate, semi-skirted (Cat. No. AB2496)

KingFisher™ 96-well Microplate (Cat. No. 97002540)

Chapter1Product information

Instrument components and plastic compatibility

20 KingFisher™ Apex Dx Puriﬁcation Instrument Instructions for Use

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Thermo Fisher Scientific KingFisher™ Apex Dx Purification Operating instructions

Thermo Fisher Scientific KingFisher™ Apex Dx Purification Operating instructions

Thermo Fisher Scientific KingFisher™ Apex Dx Purification Operating instructions

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